Biopsy device with translating valve member

ABSTRACT

A biopsy device includes a needle extending distally from a body. The needle includes a transverse aperture, a first lumen, and a second lumen. A cutter is movable within the first lumen to sever tissue protruding through the transverse aperture. A valve assembly is operable to change the pneumatic state of the second lumen. The valve assembly includes a valve body and a translating member slidably disposed in a bore of the valve body. The valve body includes a first port and a second port. The first port is in fluid communication with the second lumen of the needle. The second port is in fluid communication with atmospheric air. The translating member selectively couples the first port with the second port based on the longitudinal position of the translating member within the bore. The translating member translates relative to the valve body based on the position of the cutter.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.13/490,613, entitled “Biopsy Device with Translating Valve Member,”filed Jun. 7, 2012, which is a continuation of U.S. patent applicationSer. No. 12/959,506, entitled “Biopsy Device With Translating ValveMember,” filed Dec. 3, 2010, which is a continuation of U.S. patentapplication Ser. No. 11/198,558, entitled “Biopsy Device withReplaceable Probe and Incorporating Vibration Insertion Assist andStatic Vacuum Source Sample Stacking Retrieval,” filed Aug. 5, 2005, thedisclosures of which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates in general to biopsy devices, and moreparticularly to biopsy devices having a cutter for severing tissue, andeven more particularly to biopsy devices for multiple sampling with aprobe remaining inserted.

BACKGROUND OF THE INVENTION

When a suspicious tissue mass is discovered in a patient's breastthrough examination, ultrasound, MRI, X-ray imaging or the like, it isoften necessary to perform a biopsy procedure to remove one or moresamples of that tissue in order to determine whether the mass containscancerous cells. A biopsy may be performed using an open or percutaneousmethod.

An open biopsy is performed by making a large incision in the breast andremoving either the entire mass, called an excisional biopsy, or asubstantial portion of it, known as an incisional biopsy. An open biopsyis a surgical procedure that is usually done as an outpatient procedurein a hospital or a surgical center, involving both high cost and a highlevel of trauma to the patient. Open biopsy carries a relatively higherrisk of infection and bleeding than does percutaneous biopsy, and thedisfigurement that sometimes results from an open biopsy may make itdifficult to read future mammograms. Further, the aestheticconsiderations of the patient make open biopsy even less appealing dueto the risk of disfigurement. Given that a high percentage of biopsiesshow that the suspicious tissue mass is not cancerous, the downsides ofthe open biopsy procedure render this method inappropriate in manycases.

Percutaneous biopsy, to the contrary, is much less invasive than openbiopsy. Percutaneous biopsy may be performed using fine needleaspiration (FNA) or core needle biopsy. In FNA, a very thin needle isused to withdraw fluid and cells from the suspicious tissue mass. Thismethod has an advantage in that it is very low-pain, so low-pain thatlocal anesthetic is not always used because the application of it may bemore painful than the FNA itself. However, a shortcoming of FNA is thatonly a small number of cells are obtained through the procedure,rendering it relatively less useful in analyzing the suspicious tissueand making an assessment of the progression of the cancer less simple ifthe sample is found to be malignant.

During a core needle biopsy, a small tissue sample is removed allowingfor a pathological assessment of the tissue, including an assessment ofthe progression of any cancerous cells that are found. The followingpatent documents disclose various core biopsy devices and areincorporated herein by reference in their entirety: U.S. Pat. No.6,273,862 issued Aug. 14, 2001; U.S. Pat. No. 6,231,522 issued May 15,2001; U.S. Pat. No. 6,228,055 issued May 8, 2001; U.S. Pat. No.6,120,462 issued Sep. 19, 2000; U.S. Pat. No. 6,086,544 issued Jul. 11,2000; U.S. Pat. No. 6,077,230 issued Jun. 20, 2000; U.S. Pat. No.6,017,316 issued Jan. 25, 2000; U.S. Pat. No. 6,007,497 issued Dec. 28,1999; U.S. Pat. No. 5,980,469 issued Nov. 9, 1999; U.S. Pat. No.5,964,716 issued Oct. 12, 1999; U.S. Pat. No. 5,928,164 issued Jul. 27,1999; U.S. Pat. No. 5,775,333 issued Jul. 7, 1998; U.S. Pat. No.5,769,086 issued Jun. 23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22,1997; U.S. Pat. No. 5,526,822 issued Jun. 18, 1996; and US PatentApplication 2003/0199753 published Oct. 23, 2003 to Hibner et al.

At present, a biopsy instrument marketed under the tradename MAMMOTOMEis commercially available from ETHICON ENDO-SURGERY, INC. for use inobtaining breast biopsy samples. These devices generally retrievemultiple core biopsy samples from one insertion into breast tissue withvacuum assistance. In particular, a cutter tube is extended into a probeto cut tissue prolapsed into a side aperture under vacuum assistance andthen the cutter tube is fully retracted between cuts to extract thesample.

With a long probe, the rate of sample taking is limited not only by thetime required to rotate or reposition the probe but also by the timeneeded to translate the cutter. As an alternative to this “long stroke”biopsy device, a “short stroke” biopsy device is described in thefollowing commonly assigned patent applications: U.S. patent applicationSer. No. 10/676,944, “Biopsy Instrument with Internal SpecimenCollection Mechanism” filed Sep. 30, 2003 in the name of Hibner et al.;and U.S. patent application Ser. No. 10/732,843, “Biopsy Device withSample Tube” filed Dec. 10, 2003 in the name of Cicenas et al. Thecutter is cycled across the side aperture, reducing the sample time.Several alternative specimen collection mechanisms are described thatdraw samples through the cutter tube, all of which allow for takingmultiple samples without removing the probe from the breast.

Even given the many advantages of such multiple sample taking corebiopsy devices, in certain applications some surgeons continue to useless expensive biopsy devices guided in real time by an ultrasonicsystem. These simple biopsy systems omit a full function control consolethat operates the cutter and vacuum assistance. Instead, a manuallycontrolled hand piece advances a cutter by either stored spring force, aconstant pneumatic pressure source, or motor power. Then the surgeonactivates a cutter motor to effect the tissue sample. Thus, the surgeonis challenged to maintain the biopsy probe at a desired surgical sitewhile manipulating the patient's breast.

Consequently, it would be desirable to provide for a core biopsy devicewith a motorized cutter that provides increased functionality such asone-handed operation with assisted multiple sample retrieval with onlyone insertion of the probe, yet be able to retain the economical aspectsof simple core biopsy devices that lack elaborate remote controlsystems.

Spring-fired core needle biopsy devices rely upon a firing mechanismthat thrusts forward a needle and a cutter to penetrate the tissue andto obtain a tissue sample rather than palpitating tissue to prolapseinto a side aperture of a probe. Frequently, a surgeon may encounter anarea of dense tissue that is more difficult to penetrate than thesurrounding tissue during core needle biopsy. In particular, the lesionor tissue mass being targeted in the biopsy procedure may be difficultto penetrate, requiring the physician to push the biopsy needle withconsiderable force and/or speed in an attempt to penetrate the lesionand collect a sample.

When encountering such an area of dense tissue, it is common forsurgeons using the type of firing core needle biopsy device describedabove to fire the device in order to penetrate the lesion and obtain asample. However, due to the length of the firing stroke of such devices,which may be as long as 0.75 inches, it is nearly impossible for thesurgeon to control the travel of the needle after firing. Consequently,the long needle stroke may cause uncertainty as to the needle tiplocation post fire. This may cause the surgeon to obtain a sample fromthe wrong area. In addition to missing the targeted tissue, long firingstrokes may cause the needle to puncture the chest wall or pierce theskin, particularly when the targeted area is near the patient's chestwall. Even if the skin is not pierced, the long travel of the needle,along with the likelihood that the needle will be pushed off course bythe force of the firing stroke, may lead to needlessly increased traumafor the patient. These spring-fired biopsy devices also yield a singlesample per insertion, thus limiting the amount of diagnostic andtherapeutic treatment that may be achieved without the increaseddiscomfort and tissue trauma from repeated insertions. Based onsurgeons' use of the long firing stroke feature of current devices toaid in penetrating tissue lesions, it is clear that the medicalcommunity sees the benefit of firing assistance when inserting a probeto the desired location.

In commonly-owned and co-pending U.S. patent application Ser. No.11/035,873, BIOPSY INSTRUMENT WITH IMPROVED NEEDLE PENETRATION toBeckman, et al., filed on Jan. 10, 2005, manual mechanisms are disclosedthat impart small reciprocating motions to the probe of a core biopsydevice to render assistance in penetrating tissue, yet cutting isperformed after the probe is properly positioned, thus avoiding takingsamples from the wrong location. While there are advantages to havingsuch cutting assistance imparted by manual actuation, it is generallydesirable to alleviate the need for the surgeon to perform thisadditional action while having to manually position the biopsy device.

Additionally, it would be desirable to provide for a hand-held corebiopsy device that automatically imparts a motion to the probe thatassists in penetrating dense tissue yet does not take a sample.

SUMMARY OF THE INVENTION

The present invention addresses these and other problems of the priorart by providing a core biopsy device having a probe assembly with aprobe support structure that holds a probe having a side aperture. Acutter tube is slidingly received by the probe and sized to translateacross the side aperture to sever prolapsed tissue. A hand pieceincludes a hand piece support structure having a lateral engagingportion that receives the probe assembly. A lead screw is attached forrotation to the hand piece support structure. A cutter carriage islongitudinally translated by rotation of the lead screw therebytranslating the cutter tube. Thereby, an economical incorporation of areplaceable probe and cutter tube into a laterally mounted assemblyallows reuse of a powered hand piece.

In one aspect consistent with other aspects of the invention, a biopsydevice includes a frame supported core biopsy probe, the frame springbiased to a housing. A motor driven cam wheel coupled to the housingurges the frame against the spring bias, imparting a reciprocatinglongitudinal movement to the core biopsy probe to assist in penetratingdense tissue.

In another aspect of the invention, a biopsy device includes thereplaceable probe assembly that engages a motor-driven carriage assemblythat sequences distal translation of a rotated cutter tube with vacuumassistance sequenced from a constant vacuum source by the position ofthe cutter tube. Thereby, advantages of consistent prolapse of tissueinto the probe is achieved with a commonly available vacuum source.

In yet another aspect of the invention, a biopsy device obtains tissuesamples that prolapse into a sample aperture in a probe needle that arethen severed by a translating cutter tube received in the probe needle.A sample straw is proximally received in the cutter tube to capturethese severed tissue samples. As these severed tissue samples aresequentially stacked in the sample straw, an indicator tube is forcedproximally out of the sample straw to give a visual indication as to thenumber of tissue samples obtained. The stored tissue samplesadvantageously are maintained in the order taken, which aids in furtherdiagnostic assessment.

In yet a further aspect of the invention, a biopsy device obtains tissuesamples that prolapse into a sample aperture in a probe needle that arethen severed by a translating cutter tube received in the probe needle.A storage tube communicates with a proximal end of the cutter tube sothat a vacuum control may apply a vacuum through the storage tube andthe cutter tube to retract severed tissue samples there through. Thestored tissue samples are also advantageously maintained in the ordertaken to aid in further diagnostic assessment.

In yet an additional aspect of the invention, a hand piece has a handpiece support structure having a lateral engaging portion operativelyconfigured to engage a probe support structure of a selected one of afirst and second probe assemblies. A lead screw translates a cuttercarriage that advances a cutter tube within a probe needle of theselected probe assembly. One probe assembly includes a sample straw thatis proximally advanced by a cutter carriage of the hand piece that islongitudinally translated by rotation of the lead screw to retracttissue samples. The other probe assembly has a storage tube thatcommunicates with the cutter tube for pneumatically retracting tissuesamples. Thereby, economical incorporation of a common hand piece may berealized while providing the clinical flexibility of choosing adisposable probe assembly with a desired approach to tissue sampleretraction.

In yet another aspect of the invention, a method of obtaining corebiopsy samples advantageously maintains samples taken in a sequentialstack to enhance diagnostic assessment thereof. This orientation isachieved by inserting a core biopsy needle into tissue, prolapsingtissue into an opening of the core biopsy needle and then translating acutter tube through the core biopsy needle to sever the prolapsed tissueto form a first tissue sample. These steps are repeated with each tissuesample being sequentially urged into a sample lumen that proximallycommunicates with the cutter tube. Thereby, the sequential stacking ismaintained for lateral retrieval and analysis.

These and other objects and advantages of the present invention shall bemade apparent from the accompanying drawings and the descriptionthereof.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the present invention, it is believed the samewill be better understood by reference to the following description,taken in conjunction with the accompanying drawings in which:

FIG. 1 is a top perspective view of a biopsy device with a disposableprobe assembly detached from a reusable hand piece, the latter with ahousing shown in phantom;

FIG. 2 is a bottom perspective view of the biopsy device of FIG. 1;

FIG. 3 is a disassembled perspective view of the disposable probeassembly of FIG. 1;

FIG. 4 is a disassembled perspective view of the reusable hand piece ofFIG. 1;

FIG. 5 is a top view of an assembled biopsy device of FIG. 1;

FIG. 6 is a front view of the biopsy device of FIG. 5;

FIG. 7 is a left side view in elevation of the biopsy device of FIG. 5;

FIG. 8 is a bottom view of the biopsy device of FIG. 5;

FIG. 9 is a front view of the biopsy device of FIG. 7 taken in crosssection along lines 9-9 through a distal cutter carriage engagement to acutter gear;

FIG. 10 is a front view of the biopsy device of FIG. 7 taken in crosssection along lines 10-10 through a proximal straw carriage and stackingstraw assembly;

FIG. 11 is a front view of the biopsy device of FIG. 7 taken in crosssection along lines 11-11 through a bayonet locking member disengagedfrom the stacking straw assembly by attaching the disposable probeassembly to the reusable hand piece;

FIG. 12 is a bottom view of the biopsy device of FIG. 7 taken inhorizontal cross section along lines 12-12 through the probe andstacking straw assembly;

FIG. 13 is a detail perspective view of a slide button, sliding spurgear, and tissue penetration gear of the biopsy device of FIG. 5;

FIG. 14 is a left side view of the probe inserted into tissue of thebiopsy device of FIG. 12 in longitudinal cross section exposing thedistally translated cutter tube, elongate straw, and indicator tube;

FIG. 15 is a left perspective view of the biopsy device of FIG. 12 withthe housing removed;

FIG. 16 is a bottom view of the biopsy device of FIG. 6 taken in crosssection along staggered lines 16-16 through a lead (translation) screwand a slide pin engaged to the cutter and straw carriages;

FIG. 17 is a bottom view of the biopsy device of FIG. 6 taken inhorizontal cross section along lines 17-17 through a pneumatic valvethat sequences vacuum assistance corresponding to cutter position;

FIG. 18 is a bottom of the biopsy device of FIG. 16 in cross sectionafter proximal retraction of the straw carriage;

FIG. 19 is a left perspective detail view of the carriages, lead screw,and sliding pin of the biopsy device of FIG. 18 with the housingremoved;

FIG. 20 is a left view in elevation of the probe in longitudinal crosssection of the biopsy device of FIG. 18 with the elongate straw andindicator tube retracted;

FIG. 21 is a bottom of the biopsy device of FIG. 18 in cross sectionwith both the cutter carriage and straw carriage retracted;

FIG. 22 is a left perspective detail view of the carriages, lead screw,and sliding pin of the biopsy device of FIG. 21;

FIG. 23 is a left view in elevation of the probe in longitudinal crosssection of the biopsy device of FIG. 21 with vacuum assistanceprolapsing tissue into the side aperture;

FIG. 24 is a bottom view of the pneumatic valve in horizontal crosssection of the biopsy device of FIG. 21;

FIG. 25 is a left perspective detail view of the carriages, lead screwand sliding pin of the biopsy device of FIG. 21 after distal translationof the cutter carriage;

FIG. 26 is a left side view of the probe in longitudinal cross sectionof the biopsy device of FIG. 25 after severing tissue;

FIG. 27 is a left side view of the probe in longitudinal cross sectionof the biopsy device of FIG. 26 with distally translated cutter andstraw carriages after taking two samples held in the elongate straw bybent up tabs with corresponding proximal extrusion of the indicatortube;

FIG. 28 is a left side detail view in elevation of a proximal portion ofthe stacking straw assembly including a mechanical diode preventingdistal movement of the indicator tube into the elongate straw;

FIG. 29 is a perspective view of the straw carriage and an engagedstacking straw assembly;

FIG. 30 is a perspective view of the straw carriage and a disengagedstacking straw assembly;

FIG. 31 is an aft view in elevation of the biopsy device of FIG. 30 withthe disengaged stacking straw assembly;

FIG. 32 is an aft view in elevation of the biopsy device of FIG. 29 withthe stacking straw assembly rotated a quarter turn into engagement;

FIG. 33 is a perspective view of the stacking straw assembly of thebiopsy device of FIG. 1 after removal and peeling apart to accesssamples;

FIG. 34 is a top perspective view of an alternative probe assembly withomitted vacuum assistance instead relying on external hand palpitationof tissue to prolapse the tissue into the side aperture of the probe forthe biopsy device of FIG. 1 to acquire tissue samples;

FIG. 35 is a bottom perspective view of the alternative probe assemblyof FIG. 34;

FIG. 36 is a disassembled perspective view of the alternative probeassembly of FIG. 34;

FIG. 37 is a disassembled perspective view of an alternative disposableassembly with a straw assembly having a luer fitting for the reusablehand piece of FIG. 1;

FIG. 38 is a left side view of an alternative probe inserted into tissuefor the reusable hand piece of FIG. 1 in longitudinal cross sectionexposing the distally translated cutter tube, elongate straw, andindicator tube and with through holes in a probe tube;

FIG. 39 is a left side view of another alternative probe inserted intotissue for the hand piece of FIG. 1 that employs pneumatic pressure toretrieve tissue samples through the cutter tube rather than a strawassembly;

FIG. 40 is a top left perspective view of an alternative proximalstacking disposable assembly incorporating the probe of FIG. 39 andbeing in an initial state before use;

FIG. 41 is a bottom right perspective view of the alternative proximalstacking disposable assembly of FIG. 40;

FIG. 42 is a disassembled perspective view of the alternative proximalstacking disposable assembly of FIG. 40;

FIG. 43 is a top left perspective view of the alternative proximalstacking disposable assembly of FIG. 40 with a retrieved tissue sampleand a retracted cutter;

FIG. 44 is a bottom right perspective view of the alternative proximalstacking disposable assembly of FIG. 43;

FIG. 45 is a top left perspective view of a flexible, peel-apartexternal tissue lumen after actuating a lumen peel-apart tab to separatean inwardly open channel holding retrieved tissue samples from anelongate seal;

FIG. 46 is a left aft perspective view of the sample holding portion ofthe alternative proximal stacking disposable assembly of FIG. 40 with adistal portion transversely cut away to expose vacuum and tissue lumens;

FIG. 47 is a disassembled perspective of the sample holding portion ofthe alternative proximal stacking disposable assembly of FIG. 40;

FIG. 48 is a left perspective view of the sample holding portion of thealternative proximal stacking disposable assembly of FIG. 40 formed of atransparent material exposing retrieved tissue samples;

FIG. 49 is a top right perspective view of a reciprocating member of thesample holding portion of the alternative proximal stacking disposableassembly of FIG. 40;

FIG. 50 is a perspective view of a translating flexible rod of thesample holding portion of the alternative proximal stacking disposableassembly of FIG. 40;

FIG. 51 is a left side view in longitudinal cross section taken throughthe translating flexible rod of the sample holding portion of thealternative proximal stacking disposable assembly of FIG. 40;

FIG. 52 is a left perspective view of the sample holding portion of thealternative proximal stacking disposable assembly of FIG. 40 with aretracted reciprocating portion;

FIG. 53 is a left perspective view of the sample holding portion of thealternative proximal stacking disposable assembly of FIG. 40 with thereciprocating portion subsequently distally advanced; and

FIG. 54 is a left perspective view of the sample holding portion of thealternative proximal stacking disposable assembly of FIG. 40 with thereciprocating portion subsequently proximally retracted.

DETAILED DESCRIPTION OF THE INVENTION

In FIGS. 1-4, a biopsy device 10 has a reusable hand piece 12 and adisposable probe 14 that enables economical taking of multiplepercutaneous core biopsy samples by accessing a standard medical vacuumpump or wall-mounted vacuum access port (not shown) through aninterfacing vacuum conduit 16. In the illustrative version, the handpiece 12 is self-powered and suitable for use in conjunction withultrasonic diagnostic imaging. The disposable probe 14 reduces theportion of biopsy device 10 that requires protective packaging to avoidcontact with sharp surfaces and to keep it sterile prior to use. Furthereconomy is accomplished by reducing the portion of the biopsy device 10that is disposed as medical waste between uses. Movable components ofthe disposable probe 14 are advantageously locked until mounted in anaccess trough 18 formed in a housing 20 of the reusable hand piece 12.It should be appreciated that one or more standard mechanical,pneumatic, or electrical latches (not shown) may be integrated into thebiopsy device 10 to secure the disposable probe 14 to the reusable handpiece 12.

With particular reference to FIG. 3, the disposable probe assembly 14includes a substantially rectangular cover 22 sized to close the accesstrough recess 18 (FIGS. 2, 4). An end slot 24 formed in the cover 20(FIGS. 1-2, 4) is closed by a probe union sleeve 26 attached to an innersurface 27 of the substantially rectangular cover 22. A core biopsyneedle (“probe”) assembly 28 passes longitudinally through the probeunion sleeve 26 and is formed by a probe tube 30 with underlying vacuumlumen 32 that communicates with a side aperture 34 through holes 35(FIG. 23) near a distal opening 36 of the probe tube 30 that is closedby a piercing tip 38. A cutter tube 40 is sized to closely fit andtranslate within an inner diameter (i.e., cutter lumen) of the probetube 30 with a length sufficient to close the side aperture 34 with aproximal end 42 extending from the probe union sleeve 26 to attach to acutter gear 44, as depicted in FIG. 1.

Proximal to the probe union sleeve 26 is an elongate slot 50 that ispart of a vacuum assist valve assembly 52. The cutter gear 44 includesdistal and proximal annular recesses 54, 56 flanking spur gear teeth 58that engage the reusable hand piece 12 as described below. A more distalannular recess 60 is gripped by a post 62 that is engaged tolongitudinally translate in an elongate post slot 64 of a distal portion66 of a vacuum valve actuator 68. A cylindrical proximal portion 70 ofthe vacuum valve actuator 68 has distal and proximal O-ring grooves 72,73 that respectively retain distal and proximal dynamic O-ring seals 74,75 that move within a distally open cylindrical valve bore 76 of a valvebody 78 molded onto an outer surface 79 of the substantially rectangularcover 22 (FIG. 2).

As described below, the vacuum valve actuator 68 selectively allowscommunication between a proximal port 80, a center port 82, and a distalport 84 (FIG. 2). In particular, with the cutter gear 44 retracted, theproximal and center ports 80, 82 are in communication. With the cuttergear translated distally, the center and distal ports 82, 84communicate. The center port 82 is attached to a distal vacuum conduit86 whose other end is connected through the rectangular cover 22 to theprobe union sleeve 26. It should be appreciated that the probe unionsleeve 26 includes pneumatic passages that communicate between aproximal end of the vacuum lumen 32 and the distal vacuum conduit 86.The distal port 84 is attached to a hose nib 88 that is exposed toatmospheric pressure. Hose nib 88 may include an air and/or salinefilter. Alternatively, hose nib 88 may be connected to a positivepressure source (e.g., fluid pump) or a negative pressure source (e.g.,vacuum pump, syringe) to aspirate fluids. Likewise, hose nib 88 may beused to lavage the tissue cavity with saline, pain medication, orbleeding control fluids. The proximal port 80 communicates through aproximal vacuum conduit 90 to the interfacing vacuum conduit 16.

With further reference to FIG. 3, a sample extraction feature isincorporated so that multiple samples may be made without the need toremove the probe assembly 28 from tissue nor even to full retract thecutter tube 40 to retract a tissue specimen to the reusable hand piece12. In the illustrative version, this feature is accomplished with astacking straw assembly 100. An elongate straw 102 is scored down itslength on opposite sides by grooves 104 defining first and second strawhalves 106, 108, whose respective proximal, outer surfaces 110, 112 areattached to triangular grips 114, 116, respectively. A locking strip 118extends distally from one triangular grip 114 and is attached along aproximal portion of the first straw half 106.

Distal and proximal tabs 120, 122 extend from the inner surface 27 ofthe substantially rectangular cover 22, each having a respective throughhole 124, 126 through which the stacking straw assembly 100 is inserted.The through holes 124, 126 are shaped to allow the locking strip 118 torotate ninety (90) degrees. A bayonet locking member 130 also extendsfrom the inner surface 27 of the substantially rectangular cover 22 justdistal and laterally offset from the through hole 124 of the distal tab120 to lock into an alignment locking slot 132 in the locking strip 118when laterally rotated. The bayonet locking member 130 prevents axialmovement of the stacking straw assembly 100. The cutter gear 44 andcutter tube 40 cannot move proximally due to contact with the stackingstraw assembly 100 and cannot move distally due to contact with theprobe union sleeve 26. By securing both the cutter gear 44 and thestacking straw assembly 100 in a full distal axial position, thedisposable probe 14 is aligned to engage the components of the reusablehand piece 12 as described below. Distal to the alignment locking slot132, a rectangular recess 134, formed in the locking strip 118, definesa distal-most locking finger 136 for engaging components of thereusuable hand piece 12 that positions the stacking straw assembly 100as described below. An indicator tube 150 has a stacked cone-shapedouter surface 152 (FIG. 14) that slides within the elongate straw 104that in turn slides within the cutter tube 40.

With particular reference to FIG. 4, the reusable hand piece 12 includesfour user controls aligned on a top surface 160 of the housing 20,specifically from most distal to most proximal: a forward motor rotationkey 162, a reverse motor rotation key 164, a saline flush key 166 and aslide button 168 for selecting insertion mode or sample taking mode. Thekeys 162-166 control a control circuit 170, which may include integralpower storage (e.g., batteries, fuel cell, etc.) for untethered use. Theforward motor rotation key 162 causes a DC motor 172 to rotate its motoroutput shaft 174 in a forward rotation. A slide spur gear 176 includesan internal keyed engagement with a longitudinal key groove 178 on themotor output shaft 174 that allows longitudinal positioning by the slidebutton 168. In particular, fore and aft brackets 180, 182 of the slidebutton 168 engage distal and aft annular grooves 184, 186 that flankspur gear teeth 188 of the slide spur gear 176.

When the slide button 168 is moved distally, the slide spur gear 176engages a tissue penetration gear 190 that spins on a common shaftcenterline 192 forward of a gearbox input gear 196. Gearbox input gear196 consists of a distal small gear 198 and a proximal large gear 200.The tissue penetration gear 190 has spur gear teeth 206 that engage theslide spur gear 176. A frame hub 212 projects proximally from the frame204 with a strike pin 214 projecting upwardly from the frame hub 212. InFIGS. 4 and 13, a circular cam wheel 216 is attached to a distal side ofthe tissue penetration gear 190. Rotating the tissue penetration gear190 urges the strike pin 214, and thus the frame 204, proximally. InFIG. 12, left and right spring cavities 218, 220 (when viewed fromabove), formed longitudinally in distal corners of the frame 204,respectively receive inwardly projecting left and right tabs 222, 224from the cover 20 and receive left and right compression springs 226,228. Movement of the frame 204 proximally compresses these compressionsprings 226, 228 that thereafter assert a restoring force.

When the slide button 168 is moved proximally into engagement with thegearbox input gear 196, specifically the distal small gear 198, alsoengages and turns a translation large input gear 230 whose shaft 232passes through an aft wall 234 of the frame 204. The proximal large gear200 of the gearbox input gear 196 engages and turns a rotation smallinput gear 236 whose shaft 238 passes through the aft wall 234. Theframe 204 includes a carriage recess 240, defined between a partition242 and the aft wall 234, that contains longitudinally aligned left sidelead (translation) screw 244 and right-side rotation spur gear 246 thatare attached for rotation respectively with the shafts 232, 238. Thepartition 242 is positioned aft of the left and right tabs 222, 224 ofthe cover 20 and also defines in part the left and right spring cavities218, 220. An unlocking cam 247 projects proximally from and islongitudinally centered on the aft wall 234 above the position of thelead (translation) screw 244 and rotation spur gear 246.

The rotation spur gear 246 engages the cutter gear 44 when thedisposable probe 14 is inserted, imparting a rotation as the cutter tube40 and cutter gear 44 translate longitudinally in response to therotation of the lead (translation) screw 244. This translation is causedby lead screw threads 248. In particular, a distal cutter carriage 250is longitudinally moved on the lead screw threads 248. Distal andproximal J-hook extensions 252, 254 project downwardly from the distalcutter carriage 250 to engage the distal and proximal annular recesses54, 56 of the cutter gear 44 (FIG. 3). Distal of the cutter carriage250, a biasing spring 256 urges against the cutter carriage 250, whichassists in engagement of the lead screw threads 248 with the distalcutter carriage 250. With reference to FIGS. 4 and 19, a sliding pin 260has a proximal carriage sliding pin retainer 266 attached to a proximalstraw carriage 258. Shaft 264 also passes through a distal carriagesliding pin retainer 270 attached to the distal cutter carriage 250.Sliding pin 260 has a proximal end 262 and a distal end 268 to preventthe sliding pin 260 from disengaging from the carriage sliding pinretainers 266, 270. A sliding pin spring 272 resides on the sliding pin260 and is constrained at each end by carriage sliding pin retainers266, 270.

With the components FIGS. 1-4 now introduced, a sequence of use of thebiopsy device 10 will be described. The interfacing vacuum lumen 16 isattached to the disposable probe assembly 14 (FIGS. 1-2). The disposableprobe assembly 14 is installed into the reusable hand piece 12 (FIGS.5-8). In so doing, the distal cutter carriage 250 engages the cuttergear 44 (FIG. 9), the proximal straw carriage 258 engages the lockingstrip 118 of the stacking straw assembly 100 (FIG. 10), and the bayonetlocking member 130 is deflected by the unlocking cam 247, longitudinallyunlocking from the alignment locking slot 132 of the locking strip 118(FIG. 11) allowing longitudinal movement of the cutter tube 40 and thestraw stacking assembly 100.

In FIGS. 12, 14, the cutter and straw carriages 250, 258 may initiallybe distally advanced to close the side aperture 34 of its probe tube 30with the cutter tube 40 and the stacking straw assembly 100 also fullydistally advanced to minimize proximal extension of its elongate straw102.

In FIG. 13, the piercing tip 38 of the core biopsy needle (probe)assembly 28 is assisted in penetrating tissue by moving the slide button168 distally to a “tissue insertion mode” wherein the slide spur gear176 engages the tissue penetration gear 190. Depression of the forwardmotor rotation key 162 turns these gears 176, 190 causing the circularcam wheel 216 to turn against strike pin 214 that creates proximallongitudinal motion of frame 204 and core biopsy needle (probe) assembly28 of approximately 0.1 inch at a rotation rate of 7 cycles per second.Left and right compression springs 226, 228 provide the restoring distallongitudinal motion to frame 204 and disposable probe 14 as left andright compression springs 226, 228 are repeatedly compressed between theforward surface of the left and right spring cavities 218, 220 as theframe 204 and the left and right tabs 222, 224 of the housing 20. Therestoring distal longitudinal motion to frame 204 and core biopsy needle(probe) assembly 28 result in a corresponding distal motion of piecingtip 38 that assists in penetrating tissue.

In FIG. 15, with the side aperture 40 positioned within the tissue totake samples, the slide button 168 is moved proximally to engage theslide spur gear 176 with the distal small gear 198 of the gearbox inputgear 196. When the forward motor rotation key 162 is depressed, the DCmotor 172 rotates in a forward direction, turning the slide spur gear176, which turns the distal small gear 198 that directly turns thetranslation large input gear 230 that is connected by the shaft 232through the aft wall 234 of the frame 204 to the lead (translation)screw 244. Meanwhile, the proximal large gear 200 of the gearbox inputgear 196 rotates the small input gear 236 that turns shaft 238 throughaft wall 234 to turn the rotation spur gear 246.

With the carriages 250, 258 distally advanced as depicted in FIGS.15-16, the cylindrical proximal portion 70 of the vacuum valve actuator68 is also distally positioned as depicted in FIG. 17. The hose nib 88is thus in fluid communication through the distal port 84, through thedistally open cylindrical valve bore 76 between distal and proximaldynamic O-ring seals 74, 75 to the center port 82 through the distalvacuum conduit 86 to the vacuum lumen 32.

In FIGS. 18-19, depression of the reverse motor rotation key 164 causesthe lead (translation) screw 244 to rotate in a reverse direction.Sliding pin spring 272 between the distal cutter carriage 250 and theproximal straw carriage 258 urges the proximal straw carriage 258 intoengagement with the lead screw thread 248, causing the straw carriage258 to move proximally as the cutter carriage 250 free wheels on anunthreaded distal portion of the lead screw 244. The straw carriage 258draws back the elongate straw 102 and the indicator tube 150 (FIG. 20).As the straw carriage 258 approaches the proximal portion of the leadscrew 244, the distal end 268 of sliding pin 260 contacts the distalcarriage sliding pin retainer 270 on distal cutter carriage 250, pullingthe distal cutter carriage 250 onto the lead screw thread 248.Thereafter, the cutter carriage 250 and the cutter tube 40 are retractedas the straw carriage 258 free wheels (FIGS. 21-22).

Alternately, sliding pin spring 272 may be replaced with a ball detentmechanism (not shown) located on frame 204 that would engage with asmall depression in proximal straw carriage 258. This alternatemechanism in conjunction with biasing spring 256 would cause both thedistal cutter carriage 250 and proximal straw carriage 258 to retractsimultaneously from their fully distal position and to advancesequentially from their fully proximal position (i.e., cutter carriage250 would fully advance and then the straw carriage 258 would advance).

At the end of the proximal movement of the cutter tube 40, vacuum valveactuator 68 is moved proximally such that the distal and proximaldynamic O-ring seals 74, 75 bracket the proximal port 80 and center port82 of the distally open cylindrical valve bore 76. Thereby, theinterfacing vacuum conduit 16 draws air through the proximal vacuumconduit 90, through the valve body 78, through the distal vacuum conduit86, and ultimately from the vacuum lumen 32 (FIG. 24). In FIG. 23, thissuction draws tissue 280 into the side aperture 34 of the probe assembly28.

It should be appreciated that in the illustrative version, the distalcutter carriage 250 does not freewheel (FIG. 21) in its proximal-mostposition. Instead, rotation of the motor is stopped as the distal cuttercarriage 250 is about to contact the proximal straw carriage 258 withclosed-loop control based on an encoder (not shown) coupled to the DCmotor 172 enabling accurate positioning of the motor output shaft 174.Alternatively, freewheeling may be incorporated at the proximal-mostposition of the distal cutter carriage 250 by adding a section of nohelical threads to the proximal end of the lead (translation) screw 244equal to the longitudinal thickness of the distal cutter carriage 250.

It should further be appreciated that free wheeling may be provided forcutter translation even without stacking straw sample retraction toavoid reliance upon other structures to block further translation ormore elaborate closed loop position control.

The forward motor rotation key 162 is depressed to advance the cuttertube 40, rotating lead (translation) screw 244 and rotation spur gear246, as depicted in FIG. 25. Due to sliding pin spring 272 betweencarriages 250, 258, only the distal cutter carriage 250 engages with thelead screw threads 248 of the lead (translation) screw 244 andtranslates distally initially cutting tissue 280, as depicted in FIG.26. Once the distal cutter carriage 250 approaches its distal-mostposition, the sliding pin 260 pulls the proximal straw carriage 258 intoengagement with the lead screw threads 248 of the lead (translation)screw 244. As the cutter carriage 250 freewheels, the elongate straw 102is distally translated to encompass a first severed tissue sample 280 a,displacing proximally the indicator tube 150 a corresponding amount.

At this point, depression of the reverse motor rotation key 164 causesretraction of the proximal straw carriage 258 (FIG. 18) with the sideaperture 134 communicating with atmospheric pressure (FIG. 17) aspreviously discussed so that the first severed tissue sample 280 aremains within the elongate straw 280 a. It should be appreciated thatrepeating the retraction and advancement of the cutter carriage 250thereafter results in a second severed tissue sample 280 b beingencompassed by the elongate straw 102 and the indicator tube 150 beingfurther proximally displaced thereby as depicted in FIG. 27. Anadditional retention feature is depicted in FIG. 27 wherein smallbent-up, proximally directed tabs 284 formed in the elongate straw 102resist distal movement of the severed tissue samples 280 a, 280 b. Thisautomated sequencing of the cutter and straw carriages 250, 258 duringretraction and advancement may be repeated a number of times to take aplurality of samples without withdrawing the probe assembly 28 fromtissue 280. The surfaces of the elongate straw 102 may be coated withlubricous materials to aid in proximal movement of tissue through theelongate straw 102 and to reduce friction between the elongate straw 102and the cutter tube 40. Likewise, to aid in proximal movement of tissuethrough the elongate straw 102, the diameter of the elongate straw 102and the cutter tube 40 may be increased slightly some distance proximalfrom their distal end to reduce the friction of the tissue through theelongate straw 102.

In FIG. 28, a proximal end of the stacking straw assembly 100 includes aone-way latch (mechanical diode) 290 that engages the stacked coneshaped outer surface 152 of the indicator tube 150 as it proximallyextends out of the elongate straw 102 preventing its being pneumaticallydrawn back into the elongate straw 102 when subsequently exposed tovacuum pressure.

In FIGS. 29, 30, the proximal straw carriage 258 is shown to includedistal and proximal J-hooks 300, 302 that encompass on three sides thestacking straw assembly 100. In particular, the rectangular recess 134formed in the locking strip 118 is sized to longitudinally bracket theJ-hooks 300, 302 with the distal locking finger 136 preventingretraction as depicted in FIG. 29 when the triangular grips 114, 116 arepositioned horizontally (FIG. 31), as would be typical before and duringuse of the biopsy device 10. The surgeon may wish to segregate samplesas they are taken or to take more samples than possible within onestacking straw assembly 100. Extraction and replacement of the stackingstraw assembly 100 is allowed by rotating the triangular grips onequarter turn counterclockwise (as viewed proximally) as depicted in FIG.32, which rotates the locking finger 136 out of alignment with theJ-hooks 300, 302 of the straw carriage 258 (FIG. 30). A new stackingstraw assembly 100 is then reinserted in reverse fashion.

In FIG. 33, samples contained in the removed stacking straw assembly 100may be accessed by pulling apart the triangular grips 114, 116 causingthe grooves 104 to peel apart the first and second straw halves 106,108, which need not be symmetric. The samples may be removedindividually or the samples and the straw half 106 portion of the straw102 in which they are located may be put directly into a formalinsolution for pathological preparation. Alternately, the samplescontained in the stacking straw assembly 100 can be removed from theelongate straw 102 with a simple plunger-like rod (not shown)eliminating the need to peel apart the straw to access the tissuesamples.

Although the integral vacuum assistance supported by a medical vacuumpump may often be advantageous, some surgeons may desire to palpitatetissue into a side aperture of a probe assembly without the assistanceof vacuum. To that end, in FIGS. 34-36, an alternative disposable probe414 is depicted that omits a vacuum valve capability that responds tothe cutter position but is otherwise identical to the afore-describeddisposable probe 14. The modified components of the disposable probeassembly 414 include a substantially rectangular cover 422 sized toclose the access trough recess 18 of the reusable hand piece 12 (notshown in FIGS. 34-36). The probe union sleeve 26, attached to the innersurface 27 of the substantially rectangular cover 422, communicatesthrough a short pneumatic conduit 425 that terminates on the outersurface 79 at a hose nib 427. Hose nib 427 may include an air and/orsaline filter. Alternatively, hose nib 427 may be connected to apositive pressure source (e.g. fluid pump) or a negative pressure source(e.g., vacuum pump, syringe) to aspirate fluids. Hose nib 427 could alsobe used to lavage the tissue cavity with saline, pain medication, orbleeding control fluids. A core biopsy needle (“probe”) assembly 428that passes longitudinally through the probe union sleeve 26 differs inthat a cutter gear 444 needs only engage and respond to the distalcutter carriage 250 (not shown in FIGS. 34-36) and not also position apneumatic valve. Cutter guide tab 445 extends out from the inner surface27 to provide a distal stop for cutter gear 444. Prior to insertion ofthe disposable probe 414 into the reusable hand piece 12 (not shown inFIGS. 34-36), the bayonet locking member 430 prevents axial movement ofthe stacking straw assembly 100. The cutter gear 444 and cutter tube 40cannot move proximally due to contact with the stacking straw assembly100 and cannot move distally due to contact with the cutter guide tab445. By securing both the cutter and straw in a fully distal axialposition, it insures that when the disposable probe 414 is inserted intothe reusable hand piece 12 that the cutter gear 444 and stacking strawassembly 100 align and engage with the correct components within thereusable hand piece 12.

In FIG. 37, an alternative disposable assembly 514 is, as described inFIG. 3 but with the stacking straw assembly 100, replaced with a strawassembly 516 having distal tube 518 attached to a proximally attachedluer fitting 520. The straw assembly 516 may be used to flush the cavity(via side aperture 34) with saline, epinephrine (or similar substancesthat reduce bleeding), or lidocane (or similar substances that reducepain) by attaching a syringe or similar device (not shown) to the luerfitting 520. To remove the saline, epinephrine, or lidocane from thetissue, the cutter tube 40 may be fully or partially retracted to insurethat the valve assist valve assembly 52 is positioned to connect thelateral lumen (distal vacuum conduit 86) with the vacuum source (and notsimply atmospheric pressure) as depicted in FIG. 24. The fluid wouldthen be drawn from the tissue cavity (via side aperture 34), through thelateral lumen (distal vacuum conduit 86) and into a canister located inline with the vacuum source (not shown).

In FIG. 38, an alternative biopsy needle (probe) assembly 628 isidentical to that depicted in FIG. 14 with the exception of a probe tube630 with through holes 631 placed proximate to the side aperture 34. Thevacuum lumen 32 thus communicates with the holes 631 in the probe tube630 as an alternate means to apply saline, epinephrine, or lidocane tothe tissue cavity. These through holes 631 allow the fluid to reach thecavity while the elongate straw 102 and indicator tube 150 remaindistally positioned in the cutter tube 40 (i.e., during the middle of abiopsy sampling procedure). In this case, the syringe would be attachedto the hose nib 88 via a stopcock fitting (not shown). With the stopcockvalve positioned to connect the syringe directly to the needle's laterallumen (distal vacuum conduit 86), when the syringe is depressed thefluid will enter the lateral lumen (distal vacuum conduit 86) and thenflow into the tissue through the through holes 631 in the wall of theprobe tube 630. The cutter tube 40 would be positioned distally (sideaperture 34 closed) while the fluid is being inserted into the cavity toprevent the tissue indicator tube 150 from being moved proximally due tothe fluid pressure. During subsequent sampling cycles, the fluid wouldthen be aspirated from the tissue cavity.

In FIGS. 39-45, an alternative proximal stacking disposable assembly 702is depicted that may also be used with the reusable hand piece 12.Pneumatic force is employed to retrieve tissue samples rather than amechanical movement from the reusable hand piece 12 that actuates astraw assembly. To that end, in FIG. 39, a core biopsy needle (“probe”)assembly 704 is formed by a probe tube 706 with a distally positionedside aperture 708. A cutter tube 710 is sized to closely fit andtranslate within an inner diameter (i.e., cutter lumen) 712 of the probetube 706 with a length sufficient to close the side aperture 708. Theprobe assembly 704 includes an underlying vacuum lumen 714 thatcommunicates with the cutter lumen 712 via through holes 716 underlyingthe side aperture 708. Both the probe tube 706 and vacuum lumen 714distally terminate in open ends that communicate with each other via acurved manifold 718 defined inside of a piercing tip 720 that isattached as a distal-most portion of the probe assembly 704. A distaltissue stop 722 projects from the piercing tip 720 into the distal openend of the probe tube 706 to maintain prolapsed tissue inside a samplingbowl 724 under the side aperture 708 within the cutter lumen 712.Prolapsing occurs under the urging of axial vacuum force through thecutter lumen 712 and lateral vacuum force through the vacuum lumen 714converging at the side aperture 708. After distal translation of therotated cutter tube 712, a tissue sample 726 resides within a distalportion of the cutter tube 712, wherein an inner diameter of the cuttertube 712 defines a tissue sample lumen 728 for guiding retrieval ofsamples 726. Rather than subsequently distally advancing a straw toencompass and retract the tissue sample 726, axial vacuum pressure asdepicted by arrow 730 is asserted against a proximal face of the tissuesample 726 through the tissue sample lumen 728 with the cooperation oflateral pneumatic pressure as depicted by arrow 732 through vacuum lumen14 and curved manifold 718 to a distal face of the tissue sample 726.

In FIGS. 40-45, the portions of the alternative proximal stackingdisposable assembly 702 capture these tissue samples 726. A proximal endof the cutter tube 710 extends through a probe union sleeve 734 toattach to a cutter gear 736. A proximal end of the vacuum lumen 714terminates within the probe union sleeve 734. The alternative proximalstacking disposable assembly 702 includes a substantially rectangularcover 738 sized to close the access trough recess 18 (FIGS. 2, 4), andomits pneumatic valve features. Instead, the distally positioned probeunion sleeve 734 attached to an inner surface 740 of the substantiallyrectangular cover 738 communicates to a distal hose nib 742 formed on anouter surface 744 of the rectangular cover 738 and to the vacuum lumen714. A hose 746 is attached to the distal hose nib 742 to selectivelyprovide pneumatic vacuum, pneumatic pressure, or fluid transfer (notshown). The alternate proximal stacking assembly 702 could likewise havea vacuum assist valve assembly 052 as depicted in FIG. 2 to selectivelyprovide pneumatic vacuum, pneumatic pressure, or fluid transfer to thevacuum lumen 714.

With particular reference to FIGS. 40, 42, a rear tube 748 is alignedproximally to the cutter tube 710 and coupled for longitudinal movementthereto, although the rear tube 748 is disengaged from the rotationalmovement of the cutter tube 710. This coupled movement may be achievedby an actuator that engages the distal cutter carriage 250 (FIG. 4) orby a circular lip and groove engagement between the cutter tube 710 andrear tube 748. The inner surface 740 of the rectangular cover 738includes four support surfaces. First, a cutter guide 750 supports thecutter tube 710 proximal to the probe union sleeve 734 and distal to amost distal position of the cutter gear 736. A distal rear tube guide752, is proximal to the most proximal position of the cutter gear 736,and a proximal rear tube guide 754, and distal to a most distal positionof a proximal locking flange 756 of the rear tube 748, to maintainalignment of the rear tube 748. A bottom half-cylinder locking flange758 at a proximal end of the rectangular cover 738 cooperates with theproximal locking flange 756 of the rear tube 748 to lock to a sampleholding portion 760 of the alternative proximal stacking disposableassembly 702. The sample holding portion 760 extends proximal to therectangular cover 738 and the reusable hand piece 712 and thus may bereadily replaced during a biopsy procedure.

A distal locking half cylindrical portion 762 engages the bottomhalf-cylinder locking flange 758. The distal locking half cylindricalportion 762 is attached to a proximal half cylindrical portion 764 toform an outer sleeve 766. A reciprocating member 768, which engages theproximal locking flange 756 of the rear tube 748 and is partiallyencompassed by the outer sleeve 766, engages and distally advances amore proximal rod 770 out of an external vacuum lumen 772 defined as aninner diameter of an external vacuum tube 773. The rod has a down turneddistal end 774 that exits an opening 776 in the proximal halfcylindrical portion 764. A flexible, peel-apart external tissue tube 777defining an external tissue lumen 778 is formed from an inwardly openchannel 780 closed by an elongate seal 782.

Rod 770 may be formed of a fluoropolymer resin material such as TEFLON™or other suitable flexible material having a low coefficient offriction. Rod 770 may be sized and shaped to conform closely to theinner diameter (i.e., vacuum lumen 772) of vacuum tube 773. The closefit between rod 770 and vacuum lumen 773, as well as the low frictionproperties of the rod 770, enable the rod 770 to translate easily withinthe vacuum lumen 772 without any loss of vacuum force through the distalend of the vacuum lumen 772. The inwardly open channel 780 mayadvantageously be formed of polyvinyl chloride or another similar typeof flexible, water insoluble material so that stacked tissue samples maybe visible. A proximal end of the open channel 780 is attached to andclosed by a lumen peel tab 784. A proximal end of the external vacuumlumen 772 is attached to a vacuum line 786 via a tubing connector 788.

In FIGS. 40, 41, the alternative proximal stacking disposable assembly702 is in an initial condition with the rod 770 at its proximal mostposition in the external vacuum lumen 772. The cutter gear 736 and thusthe rear tube 748, reciprocating member 768 and flexible, peel-apartexternal tissue lumen 778 are in their distal most position. In FIGS.43, 44, the rod 770 has extruded distally out of the opening 776 in theproximal half cylindrical portion 764 of the outer sleeve 766, denotingreciprocating cycles to retract at least one tissue sample (not shown)that is held within a proximal portion of the external tissue lumen 778.The cutter gear 736 and thus the rear tube 748, reciprocating member 768and flexible, peel-apart external tissue lumen 778 are in their proximalmost positions relative to the outer sleeve 766 and rectangular cover738. The relative change causes the flexible, peel-apart external tissuelumen 778 to bow away from the outer sleeve 766. In FIG. 45, the lumenpeel tab 784 has been pulled to separate the inwardly open channel 780from the elongate seal 782 to reveal and possibly access stored tissuesamples (not shown).

In FIGS. 46-48, the sample holding portion 760 is depicted in greaterdetail. The distal locking half cylindrical portion 762 of the outersleeve 766 includes upper lateral locking arms 790 that lock into thebottom half-cylinder locking flange 758 at the proximal end of therectangular cover 738. In FIGS. 46, 47, aligned below these, lowerlateral locking arms 792 of a distal interface portion 794 of thereciprocating member 768 lock into the proximal locking flange 756 ofthe rear tube 748. The distal interface portion 794 of the reciprocatingmember 768 includes an axially-extending bore 796 for connecting theexternal tissue lumen 778 of the sample holding portion 760 to the reartube 748, maintaining generally coaxial alignment of the probe assembly702, tissue sample lumen 728, rear tube 748, bore 796, and externaltissue lumen 778 to provide an unobstructed passageway for theaspiration of tissue samples from the cutter tube 710.

In FIGS. 48, 50-51, the flexible rod 770 may be advanced distally withinthe external vacuum lumen 772 by the interaction between side ratchetteeth 798 and a pawl-type latching mechanism 800 on the reciprocatingmember 768, which is shown in greater detail in FIG. 49. Reciprocatingmember 768 may be supported on lower lateral latch arms 792 andreciprocate as cutter tube 710 is advanced and retracted. Reciprocatingmember 768 may have a bifurcated proximal end with proximally extendingportions 802 separated by an axially extending slot 804. A rampedsurface 806 is formed between portions 802 at a distal end of slot 804.Ramped surface 806 may serve to deflect the distal end 774 of rod 770through the opening 776 in the outer sleeve 766 as the rod 770 isratcheted out of external vacuum lumen 772. Unidirectional engagementpawls 808 formed to inwardly extend from the proximally extendingportions 802 into the axially extending slot 804 engage side ratchetteeth 798 on rod 770 as the rod 770 extends through the axiallyextending slot 804. The engagement between pawls 808 and side ratchetteeth 798 advances rod 770 distally through vacuum lumen 772.

In FIG. 51, a plurality of small holes 810 may be formed in a centerwall divider 812 of the external vacuum tube 773 between external vacuumlumen 772 and tissue lumen 778. Small holes 810 enable vacuum from asource (not shown) connected to vacuum line 786 to communicate fromexternal vacuum lumen 772 into external tissue lumen 778, to providevacuum in tissue sample lumen 728 in cutter tube 710. Small holes 810may be spaced along the longitudinal axis of tube vacuum tube 773 andseparated by a distance in the range of 0.1 to 4 centimeters. Holes 810may be oriented at an angle relative to the longitudinal axis of vacuumtube 773. The angle in holes 810 may function as a mechanical diode, inthat the edge of the holes 810 opening into the tissue lumen 778 may aidin preventing motion of tissue samples 726 in a distal direction, whilepermitting tissue samples 726 to move proximally in tissue lumen 778under vacuum force provided by the vacuum line 786. A tissue sample 726may continue to slide proximally through the tissue lumen 778 until thesample 726 contacts either a proximal tissue stop 812 attached to thelumen peel tab 784 or a preceding tissue sample 726.

With further reference to FIG. 51, small holes 810 may be formed betweenlumens 772, 778 by boring top holes 813 into an upper surface 814 ofexternal vacuum tube 773 with the sharpened tip of a drill or otherappropriate instrument. The tip of the drill bit or other boringinstrument may be directed to pass through vacuum lumen 772 to penetratethe center wall divider 812 that separates the two lumens 772, 778. Theproximal half cylindrical portion 764 of the outer sleeve 766 may besecurely attached to the upper surface 814 of the external vacuum tube773 following the drilling of vacuum communication small holes 810 toseal top holes 813. For instance, outer sleeve 766 may be attached tothe external vacuum tube 773 by an adhesive or other appropriate type ofattachment mechanism.

As tissue samples 726 are stored in tissue lumen 778, the stack ofsamples 726 will grow in length distally in tissue lumen 778. Thesamples 726 will tend to block or otherwise restrict flow communicationthrough small holes 810 as the stack of samples 726 extends distally intissue lumen 778. The translating flexible rod 770 is shown disposed atleast partially in vacuum lumen 772. Rod 770 extends axially throughvacuum lumen 772 to selectively cover or otherwise block at least someof the small holes 810. Rod 770 may be manipulated, such as by axialmovement of rod 770, to selectively expose small holes 810 in the vacuumtube 773 in compensation for those holes 810 blocked by stacked tissuesamples 726. For instance, during each cutting cycle, rod 770 may beadvanced distally within vacuum lumen 772 to expose or otherwiseunblock/open additional small holes 810 as additional samples 726 arestored in tissue lumen 778. The movement of rod 770 maintains apredetermined number of small holes 810 open to provide flowcommunication between vacuum and tissue lumens 772 and 778 as additionaltissue samples 726 are added to the stack of tissue samples 726 intissue lumen 778, thereby facilitating a generally consistent vacuumforce, depicted as arrow 816, in tissue sample lumen 728 in the probeassembly 704 (FIG. 39) throughout multiple cutting cycles.

Initially as depicted in FIG. 52, flexible rod 770 may be insertedwithin vacuum lumen 772 such that rod 770 is axially offset withinvacuum lumen 772 so as to cover or otherwise block most, but not all, ofthe small holes 810. For instance, prior to storing any samples 726 intissue lumen 778, rod 770 may be offset distally within vacuum lumen 772a distance that is slightly longer than the length of side aperture 708(FIG. 40). Offsetting rod 770 distally within the vacuum lumen 772ensures an initial set of small holes 810 are exposed to communicateaxial vacuum force 730 to side aperture 708 when cutter tube 710 is inthe fully proximal position prior to tissue sampling. The axial vacuumforce 730 communicated through the exposed small holes 810 aids inprolapsing tissue into side aperture 708 prior to cutting, as well aspulling the tissue sample 726 proximally into tissue lumen 778 aftercutting. As a tissue sample 726 is drawn into and stacked within tissuelumen 778, the tissue sample 726 blocks the previously exposed smallholes 810, preventing vacuum from passing into the tissue lumen 778. Rod770 may be selectively moved a predetermined distance distally that isslightly longer than the length of side aperture 708 to exposeadditional small holes 810 immediately distal of the most recentlyacquired tissue sample 726. Rod 770 may be adapted to be automaticallyadvanced distally by the translation of the cutter carriage 250. Thenewly exposed small holes 810 continue the communication of vacuum force816 into tissue lumen 778 for the next cutting cycle. As reciprocatingmember 768 retracts proximally, unidirectional bottom ratchet teeth 818located on the bottom side of flexible rod 770 engage the small holes810 within vacuum lumen 772. The engagement between the bottom ratchetteeth 818 and small holes 810 prevents rod 770 from moving proximallywithin vacuum lumen 772. As pawls 808 move proximally relative to rod770, the pawls 808 engage the next proximal set of side ratchet teeth798 on rod 770. This engagement with the next set of side ratchet teeth798 causes rod 770 to again advance distally when the reciprocatingmember 768 advances distally during the next cutting cycle to exposeadditional small holes 810. In the event that the cutter tube 710, andthus the reciprocating member 768, is advanced and retracted without theprobe assembly 704 in tissue, the result is that the flexible rod 770advances too far distally relative to the tissue samples 726; theflexible rod 770 may be rotated a fraction of a turn about itslongitudinal axis to disengage side ratchet teeth 798 and pawls 808allowing the flexible rod 770 to be repositioned proximally within thevacuum lumen 772.

A similar sample holding portion is described in five commonly-owned andco-pending U.S. patent application Ser. No. 10/953,834, “BiopsyApparatus and Method” END-5469; Ser. No. 10/953,904 “Improved BiopsyApparatus and Method” END 5470; Ser. No. 10/953,397 “Fluid Control forBiopsy Device” END 5471; Ser. No. 10/953,395 “Biopsy Device with SampleStorage” END 5472; and Ser. No. 10/953,389 “Cutter for Biopsy Device”END 5473, all to Hibner et al. and filed on 29 Sep. 2004, thedisclosures of which are hereby incorporated by reference in theirentirety.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the spirit and scope of the appendedclaims. Additionally, each element described in relation to theinvention may be alternatively described as a means for performing thatelement's function.

For example, one or more sensors may be incorporated into the hand piece12 to sense the actual position of each carriage or to sense theparticular disposable probe assembly assembled into the hand piece 12.

We Claim:
 1. A biopsy device comprising, (a) a body; (b) a needleextending distally from the body; (c) a cutter, wherein the cutter ismovable relative to the needle to sever tissue; and (d) a tissue sampleholder in communication with the cutter, wherein the tissue sampleholder is proximally removable from the biopsy device relative to alongitudinal axis defined by the needle, wherein the biopsy device isoperable to sever at least one tissue sample via the cutter andtransport the at least one tissue sample to the tissue sample holder,wherein the tissue sample holder includes a visual indicator, whereinthe visual indicator is configured to indicate a number of tissuesamples disposed within the tissue sample holder, wherein the tissuesample holder further includes a tube, wherein the tube is configured toreceive at least one tissue sample.
 2. The biopsy device of claim 1,wherein the tissue sample holder is configured to receive a plurality oftissue samples.
 3. The biopsy device of claim 1, wherein the tissuesample holder includes at least one grip, wherein the at least one gripis configured to be grasped to thereby remove the tissue sample holderfrom the biopsy device.
 4. The biopsy device of claim 1, wherein theindicator is co-axially disposed within the tube, wherein the indicatoris configured to be driven relative to the tube by at least one tissuesample being received by the tube.
 5. The biopsy device of claim 4,wherein the tube is coaxial with the cutter.
 6. The biopsy device ofclaim 5, wherein the tube is a split tube.
 7. The biopsy device of claim1, wherein the tissue sample holder is movable relative to the cutter toreceive the at least one tissue sample.
 8. The biopsy device of claim 7,wherein the tissue sample holder and the cutter are movable along acommon axis.
 9. The biopsy device of claim 1, wherein the biopsy deviceis configured to translate the cutter to sever the at least one tissuesample, wherein the biopsy device is configured to translate the tissuesample holder to receive a tissue sample in the tissue sample holder.10. The biopsy device of claim 1, wherein the biopsy device isconfigured to simultaneously translate the cutter and the tissue sampleholder to simultaneously sever the at least one tissue sample and toreceive the at least one tissue sample in the tissue sample holder. 11.The biopsy device of claim 1, wherein at least a portion of the tissuesample holder is proximal relative to the cutter.
 12. The biopsy deviceof claim 1, wherein at least a portion of the tissue sample holder isdisposed within the cutter.
 13. The biopsy device of claim 1, whereinthe tissue sample holder is configured to receive tissue samples fromthe cutter through proximal movement of the tissue samples through thecutter provided by a vacuum.
 14. A biopsy device comprising: (a) a body;(b) a needle extending distally from the body; (c) a cutter movablerelative to the needle to sever tissue adjacent to the needle; (d) atissue sample holder configured to receive a plurality of tissuesamples, wherein the tissue sample holder is movable relative to thecutter to receive each tissue sample; and (e) a visual indicator,wherein the visual indicator is configured to indicate a number oftissue samples disposed within the tissue sample holder.
 15. The biopsydevice of claim 14, wherein the tissue sample holder further includes atube, wherein the tube is configured to receive at least one tissuesample.
 16. The biopsy device of claim 15, wherein the tube is coaxialwith the cutter.
 17. The biopsy device of claim 15, wherein the visualindicator is coaxially disposed within the tube, wherein the visualindicator is configured to be driven relative to the tube by at leastone tissue sample being received by the tube.
 18. The biopsy device ofclaim 14, wherein the biopsy device is configured to translate thecutter to sever the at least one tissue sample, wherein the biopsydevice is configured to translate the tissue sample holder to receive atissue sample in the tissue sample holder.
 19. The biopsy device ofclaim 14, wherein the biopsy device is configured to simultaneouslytranslate the cutter and the tissue sample holder to simultaneouslysever the at least one tissue sample and to receive the at least onetissue sample in the tissue sample holder.
 20. The biopsy device ofclaim 14, wherein the tissue sample holder is configured to receivetissue samples from the cutter through proximal movement of the tissuesamples through the cutter provided by a vacuum.
 21. The biopsy deviceof claim 14, wherein the visual indicator includes a stacked cone-shapedouter surface, wherein the stacked cone-shaped outer surface isconfigured to extend out of at least a portion of the tissue sampleholder thereby preventing the visual indicator from being pneumaticallydrawn back into the portion of the tissue sample holder.